Commission Implementing Regulation (EU) 2026/154 of 23 January 2026 concerning the authorisation of sepiolitic clay as a feed additive for all animal species other than ruminants for milk production or reproduction, weaned piglets of porcine species, porcine species for fattening, salmonids and chickens for fattening and amending Implementing Regulation (EU) 2023/263 as regards the terms of the authorisation of sepiolitic clay as a feed additive for salmonids and chickens for fattening

Official Journal EN of the European Union L series 2026/154 26.1.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/154 of 23 January 2026 concerning the authorisation of sepiolitic clay as a feed additive for all animal species other than ruminants for milk production or reproduction, weaned piglets of porcine species, porcine species for fattening, salmonids and chickens for fattening and amending Implementing Regulation

(EU) 2023/263 as regards the terms of the authorisation of sepiolitic clay as a feed additive for salmonids and chickens for fattening (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(1), and in particular Article 9(2) and Article 13(3) thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2).

(2) The substance sepiolitic clay was authorised for a period of 10 years as a feed additive for dairy ruminants, weaned and fattening Suidae, salmonids and chickens for fattening by Commission Implementing Regulation

(EU) 2023/263(3).

(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of sepiolitic clay as a feed additive for all animal species other than dairy ruminants, weaned and fattening Suidae, salmonids and chickens for fattening, requesting the additive to be classified in the additive category ‘technological additives’ and in the functional groups ‘binders’ and ‘anticaking agents’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4) In accordance with Article 13(3) of Regulation (EC) No 1831/2003, an application was submitted for the modification of the terms of the authorisation of sepiolitic clay as laid down in Implementing Regulation

(EU) 2023/263 as regards the use for salmonids and chickens for fattening. The modification concerns an increase of the maximum content to 20 000 mg per kg of complete feed, instead of the currently authorised levels of 17 600 mg/ kg for salmonids and 10 000 mg/kg for chickens for fattening. Supplementary data were provided to demonstrate that the additive meets the conditions for authorisation at the proposed level. That modification is to be considered within the context of the re-evaluation of the substance.

(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1, ELI: http://data.europa.eu/eli/dir/1970/524/oj).

(3) Commission Implementing Regulation (EU) 2023/263 of 7 February 2023 concerning the authorisation of sepiolitic clay as a feed additive for dairy ruminants, weaned and fattening Suidae, salmonids and chickens for fattening (OJ L 37, 8.2.2023, p. 1, ELI: http:// data.europa.eu/eli/reg_impl/2023/263/oj).

ELI: http://data.europa.eu/eli/reg_impl/2026/154/oj 1/9EN OJ L, 26.1.2026

(5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 March 2025(4)that, the use of sepiolitic clay at 20 000 mg/kg complete feed is safe for all animal species, consumers and the environment. The Authority also concluded that the additive is not considered an eye or skin irritant. However, it was considered a respiratory and dermal sensitiser. Due to the dusting potential and its silica content, the additive was considered a risk by inhalation. The Authority concluded that the additive is efficacious as a binder and anticaking agent in feed for all animal species under the proposed conditions of use. It did not consider that there is a need for specific requirements of post-market monitoring.

(6) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning another application for the authorisation of the same additive and verified by the Authority in its opinion of 4 May 2022(5)are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005(6), an evaluation report of the Reference Laboratory is therefore not required.

(7) In view of the above, the Commission considers that sepiolitic clay satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that additive should be authorised for all animal species other than ruminants for milk production or reproduction, weaned piglets of porcine species, porcine species for fattening, salmonids and chickens for fattening. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

(8) In addition, in view of the above, the Commission considers that the authorisation of sepiolitic clay still meets the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 when modifying the terms thereof as regards the use for salmonids and chickens for fattening, by increasing the maximum content to 20 000 mg per kg of complete feed. Implementing Regulation (EU) 2023/263 should therefore be amended accordingly.

(9) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of sepiolitic clay for salmonids and chickens for fattening, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the modification of the authorisation concerned.

(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1 Authorisation The substance specified in Annex I, belonging to the additive category ‘technological additives’ and to the functional groups ‘binders’ and ‘anticaking agents’ is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Amendment to Implementing Regulation (EU) 2023/263 The Annex to Implementing Regulation (EU) 2023/263 is replaced by Annex II to this Regulation.

(4) EFSA Journal2025; 23:e9365. https://doi.org/10.2903/j.efsa.2025.9365.

(5) EFSA Journal2022; 20(5):7344. https://doi.org/10.2903/j.efsa.2022.7344.

(6) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/ 2005/378/oj).

2/9 ELI: http://data.europa.eu/eli/reg_impl/2026/154/ojEN OJ L, 26.1.2026 Article 3 Transitional measures

1. The substance sepiolitic clay, as authorised by Implementing Regulation (EU) 2023/263, and premixtures containing this substance, which are intended for salmonids and chickens for fattening, and which are produced and labelled before 15 August 2026 in accordance with the rules applicable before 15 February 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.

2. Compound feed and feed materials containing the substance referred to in paragraph 1, which are intended for salmonids and chickens for fattening, and which are produced and labelled before 15 February 2027 in accordance with the rules applicable before 15 February 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.

Article 4 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 23 January 2026.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2026/154/oj 3/9ANNEX Ι Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method mg of additive/kg of complete authorisation feed additive animal feed with a moisture content of 12 %

Category: technological additives. Functional group: binders 1g563 Sepiolitic clay Additive composition All animal - 20 000 1. In the directions for use 15 February Hydrated magnesium silicate of species other of the additive and 2036 sedimentary origin, containing ≥ 40 % than ruminants premixtures, the storage sepiolite and ≥ 25 % illite. for milk conditions shall be Powder form. production or indicated.

reproduction, Characterisation of the active substance weaned piglets 2. For users of the additive Sepiolite (hydrous magnesium of porcine and premixtures, feed silicate): ≥ 40 % species, porcine business operators shall

CAS number: 63800-37-3 species for establish operational

Einecs number: 264-465-3 fattening, procedures and

Chemical formula: salmonids and organisational measures Mg 4Si 6O 15(OH) 2·6H 2O. chickens for to address potential risks Illite (potassium and iron aluminium fattening resulting from their use. silicate): ≥ 25 % Where those risks

CAS number: 12173-60-3 cannot be eliminated by

Einecs number: 601-803-4 such procedures and

Chemical formula: (K,H 3O)(Al,Mg, measures, the additive Fe) 2(Si,Al) 4O 10[(OH) 2·(H 2O)] and premixtures shall be Carbonates (dolomite, calcium and used with personal magnesium carbonate): ≤ 35 % protective equipment, Free of asbestos(1) including skin and

Impurities: breathing protection.

Nickel ≤ 20,3 mg/kg Particular attention shall be given to compliance with Union legislation on the protection of workers from the inhalation risks related to exposure to crystalline silica and nickel.

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ELI:

http://data.europa.eu/eli/reg_impl/2026/154/oj EN OJ L,

26.1.2026Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method mg of additive/kg of complete authorisation feed additive animal feed with a moisture content of 12 % Analytical method(2) For the characterisation of the feed

additive: — X-ray diffraction (XRD) and — X-ray fluorescence (XRF) or atomic absorption spectrometry (AAS).

(1) The methods employed were: X-Ray diffraction and Scanning electron microscopy (SEM) with punctual Energy Dispersive X-Ray Analysis (EDAX).

(2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en.

Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method mg of additive/kg of complete authorisation feed additive animal feed with a moisture content of 12 %

Category: technological additives. Functional group: anticaking agents 1g563 Sepiolitic clay Additive composition All animal - 20 000 1. In the directions for use 15 February Hydrated magnesium silicate of species other of the additive and 2036 sedimentary origin, containing ≥ 40 % than ruminants premixtures, the storage sepiolite and ≥ 25 % illite. for milk conditions shall be Powder form. production or indicated.

reproduction, Characterisation of the active substance weaned piglets 2. For users of the additive Sepiolite (hydrous magnesium of porcine and premixtures, feed silicate): ≥ 40 % species, porcine business operators shall

CAS number: 63800-37-3 species for establish operational

Einecs number: 264-465-3 fattening, procedures and salmonids and organisational measures chickens for to address potential risks fattening

ELI:

http://data.europa.eu/eli/reg_impl/2026/154/oj 5/9 OJ L,

26.1.2026 ENMinimum Maximum content content Identification Species or Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method mg of additive/kg of complete authorisation feed additive animal feed with a moisture content of 12 %

Chemical formula: resulting from their use.

Mg Si O (OH) ·6H O. Where those risks 4 6 15 2 2 Illite (potassium and iron aluminium cannot be eliminated by silicate): ≥ 25 % such procedures and

CAS number: 12173-60-3 measures, the additive

Einecs number: 601-803-4 and premixtures shall be

Chemical formula: (K,H O)(Al,Mg, used with personal 3 Fe) (Si,Al) O [(OH) ·(H O)] protective equipment, 2 4 10 2 2 Carbonates (dolomite, calcium and including skin and magnesium carbonate): ≤ 35 % breathing protection.

Free of asbestos(1) Particular attention shall

Impurities: be given to compliance Nickel ≤ 20,3 mg/kg with Union legislation on the protection of Analytical method(2) workers from the For the characterisation of the feed inhalation risks related

additive: to exposure to crystalline — X-ray diffraction (XRD) and silica and nickel. — X-ray fluorescence (XRF) or atomic absorption spectrometry (AAS).

(1) The methods employed were: X-Ray diffraction and Scanning electron microscopy (SEM) with punctual Energy Dispersive X-Ray Analysis (EDAX).

(2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en.

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http://data.europa.eu/eli/reg_impl/2026/154/oj EN OJ L,

26.1.2026ANNEX II Minimum Maximum content content Identification Name of the Composition, chemical formula, Species or category of End of period of number of the Maximum age Other provisions additive description, analytical method animal mg of additive/kg of complete authorisation feed additive feed with a moisture content of 12 %

Category: technological additives. Functional group: binders 1g563 Sepiolitic clay Additive composition — Ruminants for - 20 000 1. In the directions for use 28 February Hydrated magnesium silicate of milk of the additive and 2033 sedimentary origin, containing production or premixtures, the storage ≥ 40 % sepiolite and ≥ 25 % illite. reproduction conditions shall be Powder form. indicated.

— Weaned piglets Characterisation of the active of porcine 2. For users of the additive substance species and premixtures, feed Sepiolite (hydrous magnesium — Porcine species business operators shall silicate): ≥ 40 % for fattening establish operational

CAS number: 63800-37-3 procedures and

Einecs number: 264-465-3 — Salmonids organisational measures

Chemical formula: — Chickens for to address potential risks Mg 4Si 6O 15(OH) 2·6H 2O. fattening resulting from their use.

Illite (potassium and iron Where those risks aluminium silicate): ≥ 25 % cannot be eliminated by

CAS number: 12173-60-3 such procedures and

Einecs number: 601-803-4 measures, the additive

Chemical formula: (K,H 3O)(Al,Mg, and premixtures shall be Fe) 2(Si,Al) 4O 10[(OH) 2·(H 2O)] used with personal Carbonates (dolomite, calcium and protective equipment, magnesium carbonate): ≤ 35 % including skin and Free of asbestos(1) breathing protection.

Impurities: Particular attention shall Nickel ≤ 20,3 mg/kg be given to compliance with Union legislation on the protection of workers from the inhalation risks related to exposure to crystalline silica and nickel.

ELI:

http://data.europa.eu/eli/reg_impl/2026/154/oj 7/9 OJ L,

26.1.2026 ENMinimum Maximum content content Identification Name of the Composition, chemical formula, Species or category of End of period of number of the Maximum age Other provisions additive description, analytical method animal mg of additive/kg of complete authorisation feed additive feed with a moisture content of 12 % Analytical method(2) For the characterisation of the

feed additive: — X-ray diffraction (XRD) and — X-ray fluorescence (XRF) or atomic absorption spectrometry (AAS).

(1) The methods employed were: X-Ray diffraction and Scanning electron microscopy (SEM) with punctual Energy Dispersive X-Ray Analysis (EDAX).

(2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en.

Minimum Maximum content content Identification Name of the Composition, chemical formula, Species or category of End of period of number of the Maximum age Other provisions additive description, analytical method animal mg of additive/kg of complete authorisation feed additive feed with a moisture content of 12 %

Category: technological additives. Functional group: anticaking agents 1g563 Sepiolitic clay Additive composition — Ruminants for - 20 000 1. In the directions for use 28 February Hydrated magnesium silicate of milk of the additive and 2033 sedimentary origin, containing production or premixtures, the storage ≥ 40 % sepiolite and ≥ 25 % illite. reproduction conditions shall be Powder form. indicated.

— Weaned piglets Characterisation of the active of porcine 2. For users of the additive substance species and premixtures, feed Sepiolite (hydrous magnesium business operators shall silicate): ≥ 40 % establish operational

CAS number: 63800-37-3 procedures and

Einecs number: 264-465-3 organisational measures to address potential risks 8/9

ELI:

http://data.europa.eu/eli/reg_impl/2026/154/oj EN OJ L,

26.1.2026Minimum Maximum content content Identification Name of the Composition, chemical formula, Species or category of End of period of number of the Maximum age Other provisions additive description, analytical method animal mg of additive/kg of complete authorisation feed additive feed with a moisture content of 12 %

Chemical formula: — Porcine species resulting from their use.

Mg Si O (OH) ·6H O. for fattening Where those risks 4 6 15 2 2 Illite (potassium and iron cannot be eliminated by — Salmonids aluminium silicate): ≥ 25 % such procedures and — Chickens for

CAS number: 12173-60-3 measures, the additive fattening

Einecs number: 601-803-4 and premixtures shall be

Chemical formula: (K,H O)(Al,Mg, used with personal 3 Fe) (Si,Al) O [(OH) ·(H O)] protective equipment, 2 4 10 2 2 Carbonates (dolomite, calcium and including skin and magnesium carbonate): ≤ 35 % breathing protection.

Free of asbestos(1) Particular attention shall

Impurities: be given to compliance Nickel ≤ 20,3 mg/kg with Union legislation Analytical method(2) on the protection of For the characterisation of the workers from the

feed additive: inhalation risks related — X-ray diffraction (XRD) and to exposure to crystalline — X-ray fluorescence (XRF) or silica and nickel. atomic absorption spectrometry (AAS).

(1) The methods employed were: X-Ray diffraction and Scanning electron microscopy (SEM) with punctual Energy Dispersive X-Ray Analysis (EDAX).

(2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en.

ELI:

http://data.europa.eu/eli/reg_impl/2026/154/oj 9/9 OJ L,

26.1.2026 EN